EP0699423A2 - Greffe tissée finement - Google Patents

Greffe tissée finement Download PDF

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Publication number
EP0699423A2
EP0699423A2 EP95302914A EP95302914A EP0699423A2 EP 0699423 A2 EP0699423 A2 EP 0699423A2 EP 95302914 A EP95302914 A EP 95302914A EP 95302914 A EP95302914 A EP 95302914A EP 0699423 A2 EP0699423 A2 EP 0699423A2
Authority
EP
European Patent Office
Prior art keywords
graft
crimps
woven textile
tubular body
wave
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP95302914A
Other languages
German (de)
English (en)
Other versions
EP0699423B1 (fr
EP0699423A3 (fr
Inventor
Peter J. Schmitt
Jose F. Nunez
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Scimed Inc
Original Assignee
Meadox Medicals Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Meadox Medicals Inc filed Critical Meadox Medicals Inc
Priority to EP03015574A priority Critical patent/EP1371345A3/fr
Publication of EP0699423A2 publication Critical patent/EP0699423A2/fr
Publication of EP0699423A3 publication Critical patent/EP0699423A3/fr
Application granted granted Critical
Publication of EP0699423B1 publication Critical patent/EP0699423B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the present invention relates generally to synthetic tubular prostheses and more particularly the present invention relates to a flexible vascular graft formed of thinly woven textile material.
  • Textile grafts are widely used to replace or repair damaged or diseased vessels of the body.
  • Textile vascular grafts may be implanted in the vascular system for the repair of arteries and veins.
  • graft implantation is conducted in a surgical procedure requiring the body to be opened adjacent to the implantation site. Improvements in medical procedures now additionally permit graft implantation to be done in a less invasive manner.
  • vascular endoscopic surgery permits certain grafts to be implanted with a hollow catheter delivery system. The catheter enters the vessel either percutaneously or through a small incision. The catheter delivery system passes the graft through the lumen of the blood vessel for deployment at the desired location.
  • a graft which is to be implanted by the catheter delivery system would also have to be as thin as possible so that it can be radially compressed and packed inside the lumen of a hollow catheter for deployment in the blood vessel.
  • the size of the graft dictates the size of the catheter employed, providing a thin graft allows use of a small diameter catheter and therefore results in less trauma during implantation.
  • the graft once implanted by the catheter delivery system, must readily return to its open tubular shape and maintain that shape during use. This is particularly important where the graft is implanted by a catheter as the graft must be tightly compressed and packed so as to fit within the hollow lumen of the catheter.
  • the present invention provides a woven textile prosthetic implant including an elongate tubular body formed of a woven fabric having a fabric thickness which is no greater than about 0.16 mm.
  • the tubular body includes a series of longitudinally spaced wave-like generally uniform crimps along the length thereof.
  • the crimps have a crimp frequency of no less than about 6 crimps per centimeter of body length.
  • the wave-like generally uniform crimps include a peak-to-peak amplitude which is no greater than about 0.5 mm. This reduces the area in which thrombus formation may take place.
  • the present invention specifically provides an intraluminally implantable graft having a wall thickness sufficiently thin such that the graft may be radially compressed for insertion into a delivery catheter for catheter implantation.
  • Figure 1 shows schematically, in partial section, a conventionally formed prosthetic graft.
  • Figure 2 shows schematically, in partial section, a prosthetic graft formed in accordance with the present invention.
  • Figure 3 shows schematically, in partial section, the present invention embodied in a bifurcated design.
  • the present invention provides an improved textile prosthetic implant. Specifically the preferred embodiment of the present invention is directed towards an implantable graft which is used to replace a damaged section of a body vessel such as a blood vessel. However, the present invention need not be limited thereto.
  • a prosthetic implant in accordance with the present invention may be used intraluminally to support any diseased or otherwise damaged body vessel.
  • Graft 10 is a textile product formed of a woven or knitted synthetic fabric in a manner which is well known in the graft art.
  • Graft 10 includes a generally tubular body 12 having opposed ends 14 and 16 which define therebetween an open lumen 18 which permits passage of blood once the graft 10 is implanted in the blood vessel.
  • the graft must be suitably pliable to adapt to the configuration of the vessel into which it is being implanted and also must be flexible enough to be handled and manipulated by the surgeon.
  • the graft must maintain a tubular configuration so that lumen 18 remains open allowing the passage of blood.
  • tubular graft 10 with a series of wave-like crimps 20 along the body thereof.
  • Crimps 20 follow a generally sinusoidal wave-like pattern continuously along the length of graft 10.
  • Crimps 20 may be imparted to graft 10 in one of a number of well-known techniques. For instance, the uncrimped tubular graft may be compressed over a mandrel and then by an application of heat, the crimp pattern will take a set. Other techniques such as disposing graft 10 over a screw-threaded mandrel and heating the mandrel, may also impart a desired crimp-like pattern to the graft.
  • the number and size of crimps on any particular graft is limited by the fabric or wall thickness of the graft.
  • the wall thickness of the graft is relatively thick, say greater than 0.20 mm, successive crimps cannot be closely spaced. That is, the graft cannot have finely pitched crimps.
  • the relative thickness of the fabric prevents the waves from being closely compacted. Accordingly in order to establish the longitudinal flexibility needed, as well as to impart sufficient tubular integrity, it is necessary to provide wave-like crimps having a relatively large amplitude.
  • the amplitude of the wave which is dictated by the thickness of the fabric, permits the graft to be longitudinally stretched so as to conform to the portion of the blood vessel which must be replaced or repaired. Further, such large amplitude crimps permit the graft to be easily flexed to permit ease of implantation and also provide a certain degree of structural stability to maintain the graft in an open tubular configuration.
  • the large amplitudes of the crimps have a tendency to promote the formation of thrombus and plaque build-up between the crimps which may be detrimental to the long-term patency of the graft.
  • the relatively large amplitude crimps provide a significantly more irregular profile of the graft wall which can undesirably increase the amount of turbulence created within the vessel.
  • Thick wall grafts having finer crimps and/or crimps of lower amplitude do not exhibit a sufficient pliancy, spring-like elasticity and structural integrity to be suitable for implantation.
  • Graft 30 is an elongate generally tubular member formed of woven synthetic fibers such as polyester. However it may be appreciated that other materials, as well as other forming techniques such as knitting may also be employed. Graft 30 includes a tubular body 32 having opposed ends 34 and 36 which define therebetween an open lumen 37. Graft 30 defines a generally tubular fabric wall 35 having a fabric thickness not exceeding about 0.16 mm.
  • An example of a graft formed in accordance with the present invention may be formed from a plain weave tubular fabric having a warp yarn of 50 denier, 48 filament flat polyester and weft yarn of 50 denier, 48 filament flat polyester. The ends per inch would be 188 per layer while the picks per inch would be 88 per layer.
  • the fabric so formed would have a wall thickness of approximately 0.12 mm.
  • the graft After weaving into a tubular graft, the graft would be scoured to remove dirt, oil and other processing agents.
  • the material may be then heat set to stabilize the graft. Heat setting can be accomplished in one of many conventionally known techniques such as heating in a steam autoclave or a conventional oven.
  • the tubular fabric can also be heat set on smooth mandrels to precisely set the diameter and to remove any creases or wrinkles. As above described, the grafts may then be crimped to impart longitudinal compliance and radial support.
  • a finer crimp pattern may be imparted to graft 30 of the present invention.
  • Crimp pattern 40 shown in Figure 2 includes a series of wave-like crimps 38 therealong. Crimps 38 may be imparted on a finer pitch as the relatively thin fabric would not impede such fine pinch crimping.
  • a graft having a maximum fabric or wall thickness of 0.16 mm could be crimped to a pitch of about 33 crimps per centimeter.
  • the amplitude of the crimps can be reduced without significantly reducing the longitudinal flexibility or structural stability of the graft. It has been found that forming a graft in accordance with the present invention, the amplitude, measured peak-to-peak, of the wave-like crimp pattern can be reduced to no greater than 0.6 mm.
  • a crimp pattern having such a small amplitude greatly reduces risk of thrombus or plaque formation on the interior of the graft.
  • the thinly woven graft of the present invention may be radially compressed for insertion within the lumen of the catheter (not shown) for catheter implantation within a body vessel.
  • the thin construction of the graft of the present invention permits such catheter implantation.
  • the above described example permits use of a small diameter endoluminal catheter which tends to reduce trauma at the insertion site.
  • catheters such as an 8 cm long balloon, PE-MT balloon angioplasty catheter manufactured by Meditech-Boston Scientific, Inc. or a 10 mm diameter by 4 cm long OLBERT® balloon catheter manufactured by Meadox Surgimed A/S may be employed for introducing and implanting graft 30.
  • the graft 30 Once deployed, the graft 30 must maintain its longitudinal flexibility as well as return to its tubular open lumen configuration.
  • the particular pattern of crimps employed with the present invention permits such longitudinal flexibility and structural integrity without increasing the graft thickness as measured both by fabric wall thickness and as measured between the peak-to-peak amplitude of the wave-like pattern of crimps.
  • Graft 30 may include a radiopaque guideline or marker. As shown in Figure 2, marker 45 may extend the length of graft 30. Other patterns for marker 45 may also be employed. Radiopaque marker 45 assists the surgeon to visualize the graft both during and after implantation. The marker 45 would help show the surgeon that the graft is properly positioned. Also, it will indicate whether the graft has dilated or collapsed after implantation. Further, during endoscopic implantation, marker 45 may be used to assist in the proper positioning of the graft.
  • radiopaque guidelines or markers may be formed from metallic fibers such as stainless steel or titanium. Also, one or more polymeric fibers may be coated or filled with radiopaque particles.
  • graft 50 is an elongate generally tubular member having a first end 54 having a single lumen extending therefrom. An opposed end 56 is bifurcated into a pair of smaller tubular members 56a and 56b. A graft of this type may be used to repair and replace a main vessel and branch vessels.
  • graft 50 is crimped in a manner described above to impart longitudinal flexibility, structural integrity and spring-like compliance.

Landscapes

  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
EP95302914A 1994-08-02 1995-04-28 Greffe tissée finement Expired - Lifetime EP0699423B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP03015574A EP1371345A3 (fr) 1994-08-02 1995-04-28 Greffe tissée finement

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US28533494A 1994-08-02 1994-08-02
US285334 1994-08-02

Related Child Applications (1)

Application Number Title Priority Date Filing Date
EP03015574A Division EP1371345A3 (fr) 1994-08-02 1995-04-28 Greffe tissée finement

Publications (3)

Publication Number Publication Date
EP0699423A2 true EP0699423A2 (fr) 1996-03-06
EP0699423A3 EP0699423A3 (fr) 1997-05-28
EP0699423B1 EP0699423B1 (fr) 2003-08-06

Family

ID=23093780

Family Applications (2)

Application Number Title Priority Date Filing Date
EP95302914A Expired - Lifetime EP0699423B1 (fr) 1994-08-02 1995-04-28 Greffe tissée finement
EP03015574A Withdrawn EP1371345A3 (fr) 1994-08-02 1995-04-28 Greffe tissée finement

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP03015574A Withdrawn EP1371345A3 (fr) 1994-08-02 1995-04-28 Greffe tissée finement

Country Status (8)

Country Link
US (2) US5697970A (fr)
EP (2) EP0699423B1 (fr)
JP (2) JPH0856968A (fr)
AU (1) AU686749B2 (fr)
CA (1) CA2147547C (fr)
DE (1) DE69531428T2 (fr)
ES (1) ES2204929T3 (fr)
FI (1) FI952213A (fr)

Cited By (11)

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Publication number Priority date Publication date Assignee Title
WO1997037616A2 (fr) * 1996-04-05 1997-10-16 Medtronic, Inc. Prothese endoluminable comportant des marqueurs d'indication de position
WO1997043983A1 (fr) 1996-05-24 1997-11-27 Meadox Medicals, Inc. Protheses tubulaires tissees et formees pour tissus mous, et procedes de fabrication
WO1998029146A1 (fr) * 1996-12-31 1998-07-09 St. Jude Medical, Inc. Marquage pour dispositif prothetique
WO2000038591A3 (fr) * 1998-12-29 2000-10-26 Tayside University Hospitals N Tubulure pour la circulation sanguine
WO2002094135A1 (fr) * 2001-05-21 2002-11-28 Aesculap Ag & Co. Kg Implant chirurgical, procede de production et utilisation
WO2006100659A1 (fr) * 2005-03-23 2006-09-28 University Of Limerick Greffe vasculaire
EP1847236A2 (fr) * 2006-04-18 2007-10-24 Medtronic Vascular, Inc. Greffe d'endoprothèse ayant une greffe de branche compressible axialement, articulable et flexible
US8226704B2 (en) 2003-03-18 2012-07-24 Veryan Medical Limited Helical stent
EP2135582A3 (fr) * 1998-03-16 2013-07-03 Teramed Incorporated Système de greffe endovasculaire biluminale
US9572694B2 (en) 2003-03-18 2017-02-21 Veryan Medical Limited Helical graft
US9597214B2 (en) 2008-10-10 2017-03-21 Kevin Heraty Medical device

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US6165213A (en) 1994-02-09 2000-12-26 Boston Scientific Technology, Inc. System and method for assembling an endoluminal prosthesis
US6051020A (en) 1994-02-09 2000-04-18 Boston Scientific Technology, Inc. Bifurcated endoluminal prosthesis
US6331188B1 (en) 1994-08-31 2001-12-18 Gore Enterprise Holdings, Inc. Exterior supported self-expanding stent-graft
US6015429A (en) 1994-09-08 2000-01-18 Gore Enterprise Holdings, Inc. Procedures for introducing stents and stent-grafts
EP0950385A3 (fr) 1995-12-14 1999-10-27 Prograft Medical, Inc. Appareil et procédé de déploiement d'un stent à greffer
US6042605A (en) 1995-12-14 2000-03-28 Gore Enterprose Holdings, Inc. Kink resistant stent-graft
US5895424A (en) * 1996-11-12 1999-04-20 Mentor Corporation Prosthesis having an alignment indicator and method of using same
US6551350B1 (en) 1996-12-23 2003-04-22 Gore Enterprise Holdings, Inc. Kink resistant bifurcated prosthesis
US6352561B1 (en) 1996-12-23 2002-03-05 W. L. Gore & Associates Implant deployment apparatus
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US6159239A (en) 1998-08-14 2000-12-12 Prodesco, Inc. Woven stent/graft structure
US6340368B1 (en) 1998-10-23 2002-01-22 Medtronic Inc. Implantable device with radiopaque ends
US6361557B1 (en) 1999-02-05 2002-03-26 Medtronic Ave, Inc. Staplebutton radiopaque marker
US6325823B1 (en) 1999-10-29 2001-12-04 Revasc Corporation Endovascular prosthesis accommodating torsional and longitudinal displacements and methods of use
US6468301B1 (en) 2000-03-27 2002-10-22 Aga Medical Corporation Repositionable and recapturable vascular stent/graft
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US6770090B2 (en) 2001-12-07 2004-08-03 Scimed Life Systems, Inc. Anatomically curved graft for implantation at the aortic arch
US7147661B2 (en) 2001-12-20 2006-12-12 Boston Scientific Santa Rosa Corp. Radially expandable stent
US8308797B2 (en) 2002-01-04 2012-11-13 Colibri Heart Valve, LLC Percutaneously implantable replacement heart valve device and method of making same
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ATE511816T1 (de) * 2003-03-31 2011-06-15 Teijin Ltd Verbund aus trägersubstrat und kollagen und verfahren zur herstellung eines trägersubstrats und verbunds
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US8177834B2 (en) 2007-03-12 2012-05-15 Cook Medical Technologies Llc Woven fabric with shape memory element strands
US8834552B2 (en) 2007-12-27 2014-09-16 Cook Medical Technologies Llc Stent graft having floating yarns
EP2349080B1 (fr) 2008-10-22 2016-04-13 Boston Scientific Scimed, Inc. Endoprothèse vasculaire tubulaire à mémoire de forme comportant des rainures
US8858613B2 (en) 2010-09-20 2014-10-14 Altura Medical, Inc. Stent graft delivery systems and associated methods
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WO2011109450A2 (fr) 2010-03-01 2011-09-09 Colibri Heart Valve Llc Valvule cardiaque pouvant être posée par voie percutanée et procédés associés
US8696738B2 (en) * 2010-05-20 2014-04-15 Maquet Cardiovascular Llc Composite prosthesis with external polymeric support structure and methods of manufacturing the same
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WO2014144809A1 (fr) 2013-03-15 2014-09-18 Altura Medical, Inc. Systèmes de pose de dispositif d'endogreffe et procédés associés
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US11395726B2 (en) 2017-09-11 2022-07-26 Incubar Llc Conduit vascular implant sealing device for reducing endoleaks
CN116899069A (zh) * 2017-12-15 2023-10-20 佩尔福兹有限公司 改进的导管和结合这种导管的装置和***
US20210236131A1 (en) * 2018-07-13 2021-08-05 University Of Tennessee Research Foundation Biodegradable intraluminal small intestinal anastomotic guide
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Citations (6)

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Publication number Priority date Publication date Assignee Title
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US9597214B2 (en) 2008-10-10 2017-03-21 Kevin Heraty Medical device
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Also Published As

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JPH0856968A (ja) 1996-03-05
CA2147547A1 (fr) 1996-02-03
FI952213A0 (fi) 1995-05-08
CA2147547C (fr) 2006-12-19
DE69531428T2 (de) 2004-08-19
FI952213A (fi) 1996-02-03
EP0699423B1 (fr) 2003-08-06
USRE40404E1 (en) 2008-06-24
DE69531428D1 (de) 2003-09-11
EP1371345A2 (fr) 2003-12-17
EP0699423A3 (fr) 1997-05-28
JP2005211684A (ja) 2005-08-11
AU1775395A (en) 1996-02-15
EP1371345A3 (fr) 2004-01-02
US5697970A (en) 1997-12-16
ES2204929T3 (es) 2004-05-01
AU686749B2 (en) 1998-02-12

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